Comparison of Two Different Pleural Drainage Systems

NCT ID: NCT03021369

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-03-31

Brief Summary

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The digital pleural drainage system Topaz+ by Medela is compared to the analogue system Atrium OCEAN by Maquet in patients undergoing cardiac surgery.

The study is prospectively randomized with an all-comer setup. The patients are randomly selected for one of the systems. The surgery is performed in the standard fashion and chest tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32 French drain is placed in every patient and pericardial and/or pleural drains are optional.

The postoperative course does not vary from the clinical standard and the chest tubes are removed according to institutional standard. The clinical data about fluid amount, time of removal, air leaks, tamponade are routinely collected in a digital patient documentation system.

Detailed Description

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Conditions

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Air Leak From Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pleural drainage system Medela

These patients receive the digital Medela system

Group Type ACTIVE_COMPARATOR

Pleural drainage system

Intervention Type DEVICE

Pleural drainage system is connected to the chest tubes after surgery.

Pleural drainage system Ocean

These patients receive the analogue Maquet system

Group Type ACTIVE_COMPARATOR

Pleural drainage system

Intervention Type DEVICE

Pleural drainage system is connected to the chest tubes after surgery.

Interventions

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Pleural drainage system

Pleural drainage system is connected to the chest tubes after surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* adult patients undergoing cardiac surgery
* capability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kerckhoff Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kerckhoff Klinik

Bad Nauheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Medela1

Identifier Type: -

Identifier Source: org_study_id

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